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Comparison of AV Optimization Methods Used in Cardiac Resynchronization Therapy (CRT)

Phase 4
Completed
Conditions
Heart Failure
Interventions
Device: AV Delay programming through cardiac resynchronization therapy
Registration Number
NCT00677014
Lead Sponsor
Boston Scientific Corporation
Brief Summary

The primary objective of SMART-AV is to assess the effect of SmartDelay for determining optimal AV delay timing during CRT compared to both a fixed AV delay and echocardiography-determined optimal AV timing chronically over a 6-month period.

Detailed Description

SMART-AV is a randomized, multi-center, double-blinded, non-significant risk, three-armed trial that will investigate the effects of optimizing AV delay timing in heart failure patients receiving CRT-D therapy. Patients will be randomized in a 1:1:1 ratio using randomly permuted blocks within each center. The study will compare chronic changes in structural and functional outcomes in CRT-D patients randomized to AV delay set as fixed, set with SmartDelay or determined by echocardiography. Patients will be followed at enrollment, implant, post-implant, 3-months post-implant and 6-months post-implant.

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
1060
Inclusion Criteria
  • Patients who meet current indications for a BSC CRT-D device with the SmartDelay algorithm
  • Patients who are willing and capable of undergoing a device implant and participating in all testing associated with the SMART-AV Study
  • Patients who are on optimal and stable pharmacologic therapy
  • Patients who are expected to be in sinus rhythm at the time of implant
  • Patients who have a life expectancy of more than 360 days, per physician's discretion
  • Patients who are geographically stable and willing to comply with the required follow-up schedule
  • Patients who are 18 years of age or above, or of legal age to give informed consent specific to state and national law
Exclusion Criteria
  • Patients who are in complete heart block, or who otherwise are unable to tolerate pacing at VVI-40 RV for up to 14 days
  • Patients undergoing an upgrade of a pacemaker or implantable cardioverter-defibrillator who are unable to tolerate pacing at VVI-40 RV for up to 14 days
  • Patients who have previously received cardiac resynchronization therapy
  • Patients who are expected to receive a heart transplant or have other cardiac surgeries or procedures planned during the course of the study
  • Patients who currently have or who are likely to receive a tricuspid valve prosthesis
  • Patients who have a neuromuscular, orthopedic, or other non-cardiac condition that prevents normal, unsupported walking
  • Patients who are pregnant or planning to become pregnant during the study
  • Patients who are currently enrolled in another investigational study or registry that would directly impact the treatment or outcome of the current study

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
Echo optimized AV delayAV Delay programming through cardiac resynchronization therapyEcho optimized AV delay
Algorithm optimized AV delayAV Delay programming through cardiac resynchronization therapyAlgorithm optimized AV delay
Fixed AV DelayAV Delay programming through cardiac resynchronization therapyFixed AV Delay
Primary Outcome Measures
NameTimeMethod
Left Ventricular End-systolic Volume (LVESV)6 months

Change in square root of absolute left ventricular end systolic volume from baseline to 6 month follow up

Secondary Outcome Measures
NameTimeMethod
Secondary Endpoints Will Include Structural and Functional MeasuresChronic

Trial Locations

Locations (1)

Medical College of Virginia

🇺🇸

Richmond, Virginia, United States

Medical College of Virginia
🇺🇸Richmond, Virginia, United States
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